NDAINHALATIONPOWDER
Approved
Mar 2013
Lifecycle
Peak
Competitive Pressure
8/100
Clinical Trials
20
Data completeness
6/8 — Strong
TOBI PODHALER (tobramycin) by Viatris (2) is clinical pharmacology: corticoids suppress the inflammatory response to a variety of agents and they probably delay or slow healing. Approved for cystic fibrosis. First approved in 2013.
Drug data last refreshed Yesterday · AI intelligence enriched 3w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
TOBI PODHALER is a tobramycin inhalation powder approved by the FDA in March 2013 for treatment of chronic Pseudomonas aeruginosa infection in cystic fibrosis patients. As an aminoglycoside antibiotic, tobramycin works by inhibiting bacterial protein synthesis in susceptible organisms including P. aeruginosa, S. aureus, and gram-negative bacteria. The product represents a key maintenance therapy option in the CF treatment paradigm, delivered via a specialized dry powder inhaler for direct lung delivery.
$0.0BPart D
4.5 years to LOEMechanism of Action
CLINICAL PHARMACOLOGY: Corticoids suppress the inflammatory response to a variety of agents and they probably delay or slow healing. Since corticoids may inhibit the body's defense mechanism against infection, a concomitant antimicrobial drug may be used when this inhibition is considered to be…
Pharmacologic Class:
Aminoglycoside Antibacterial
Indications (1)
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Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.